- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03379805
Lymphatic Function in Patients With a Fontan-Kreutzer Circulation
The Lymphatic Morphology and Function of Fontan-Kreutzer Operated Patients
The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an extremely important step in the prevention of edema. The Fontan-Kreutzer procedure has revolutionized the treatment of univentricular hearts. However, it is associated with severe complications such as protein-losing enteropathy (PLE) and peripheral edema that may involve the lymphatic circulation.
Our hypothesis is that patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE.
The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF. The anatomy is described using non-contrast MRI and the capillary filtration rate is measured using plethysmography.
Study Overview
Status
Detailed Description
Background:
The lymphatics regulate the interstitial fluid by removing excessive fluid. It represents an extremely important step in the prevention of edema. The Fontan-Kreutzer procedure has revolutionized the treatment of univentricular hearts. However, it is associated with severe complications such as protein-losing enteropathy (PLE) and peripheral edema that may involve the lymphatic circulation.
Hypothesis:
Patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature, which predisposes them to developing complications such as edema and PLE.
Material and Methods:
The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF. The anatomy is described using non-contrast MRI and the capillary filtration rate is measured using plethysmography. The study population is patients with Fontan-Kreutzer circulation operated at Aarhus University hospital. Exclusion criteria is BMI>30 and age (years) < 18. The Fontan-Kreutzer group will be compared with an age, gender and weight matched control group of healthy volunteers.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Fontan-Kreutzer circulation
Exclusion Criteria:
- BMI>30,
- Age<18
- Mental illness
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fontan-Kreutzer operated patients
Patients with a Fontan-Kreutzer circulation.
No interventions are done.
(The intervention is the operation done 15-20 years ago)
|
The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.
Other Names:
The anatomy is described using non-contrast MRI.
The capillary filtration rate is measured using plethysmography
|
Healthy Control subjects
Age, gender and weight matched control subjects
|
The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.
Other Names:
The anatomy is described using non-contrast MRI.
The capillary filtration rate is measured using plethysmography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pumping pressure
Time Frame: 1 hour
|
Occlusion of lymphatic flow by inflating a cuff (Hokanson E20 Rapid cuff inflator, Hokanson AG101 air source) to 70mmHg and then reducing the pressure with 5mmHg each 5th minute.
The highest pressure under which the fluorescent dye is able to cross the inflatable cuff is labelled Ppump.
|
1 hour
|
Contraction Frequency
Time Frame: 6 min
|
Contraction frequency in vessels in the main drainage pathway of the legs (ventromedial bundle) as well as vessels draining the area behind the medial malleolus.
|
6 min
|
Refill time
Time Frame: 20 min
|
The time it takes for a 10 cm long vessel to refill after emptying the vessel with massage
|
20 min
|
Velocity
Time Frame: 6 min
|
The velocity measured in cm/s for a packet of lymph moving from one region of interest (ROI) to another through atlas a 5 cm straight vessel
|
6 min
|
Capillary Filtration Rate
Time Frame: 25 min
|
A 5-step 20-min venous congestion protocol will be used to measure capillary filtration.
The capillary filtration rate (µl·100 ml-1 ·min-1 ) is measured as the slope of the time-volume change (%) curve at steady state at the end of each pressure phase.
|
25 min
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vibeke E Hjortdal, MD, PhD, Dr.Med, Aarhus University Hospital, Department of Cardiothoracic and Vascular Surgery
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fontan17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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